Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix

Last updated: February 24, 2025
Sponsor: Zagazig University
Overall Status: Completed

Phase

N/A

Condition

Miscarriage

Treatment

cervical cerclage

Clinical Study ID

NCT05338164
ZU-IRB #8090/17-10-2021
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18-45 years.

  • Dichorionic twins.

  • Transvaginal sonographic cervical length is <25 mm with or without internal osdilatation ≥10 mm at 14-20 weeks gestational age.

  • Asymptomatic.

Exclusion

Exclusion Criteria:

  • Triplets and quadruplets.

  • Monochorionic twins.

  • Threatened/ inevitable miscarriage

  • Bulging membranes through the external os.

  • Extremes of age.

  • Major fetal anomalies.

  • Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis... etc.

  • Fetal demise.

  • Fetal reduction in the current pregnancy.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: cervical cerclage
Phase:
Study Start date:
December 20, 2021
Estimated Completion Date:
October 31, 2024

Study Description

Introduction Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant mortality.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births.5 However, there is growing evidence of beneficial effect of applying cervical cerclage. Based on a few, small, controlled trials, cervical cerclage may extend the pregnancy, if it is applied to a cervix of less than 15 mm.6,7 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.

Rationale:

Pregnant in twins with history suggesting cervical weakness and evidence of shortened cervix in the current pregnancy might get benefit from mechanical support by cervical cerclage in trial to reduce the risk of preterm birth.

Connect with a study center

  • Faculty of medicine, Zagazig University

    Zagazig, Sharkia 44519
    Egypt

    Site Not Available

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